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AstraZeneca’s Calquence Regimen Gains EU Approval Recommendation for CLL

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An update from AstraZeneca ( (GB:AZN) ) is now available.

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval for a fixed-duration regimen of its drug Calquence, in combination with venetoclax, with or without obinutuzumab, for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) in the EU. This recommendation is based on the AMPLIFY Phase III trial results, which demonstrated significant improvements in progression-free survival compared to standard chemoimmunotherapy. The approval could position Calquence as a leading treatment option in Europe, offering patients a more flexible and potentially safer treatment regimen.

Spark’s Take on GB:AZN Stock

According to Spark, TipRanks’ AI Analyst, GB:AZN is a Outperform.

AstraZeneca’s strong financial performance and promising earnings call results are key strengths, supported by robust revenue and EPS growth. However, technical analysis indicates potential short-term weakness, and the stock appears overvalued on a P/E basis, which offsets some of the positives. Challenges in China and regulatory impacts also pose risks, but the company’s strategic initiatives and new drug approvals provide long-term growth potential.

To see Spark’s full report on GB:AZN stock, click here.

More about AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide.

YTD Price Performance: 0.80%

Average Trading Volume: 2,918,273

Technical Sentiment Signal: Hold

Current Market Cap: £161.3B

For an in-depth examination of AZN stock, go to TipRanks’ Stock Analysis page.

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